Academics, former regulators and other scientists challenge WHO cancer agency classification schemes as outmoded

Oct 25, 2016 – Ten prominent experts in toxicology, oncology, pharmacology, biology, endocrinology, genetics and related disciplines who have worked across academe, government and commercial product research, development and regulation published views in the official journal of the International Society for Regulatory Toxicology and Pharmacology stating the International Agency for Cancer Research (IARC) and United Nations Global Harmonized System for Classification and Labeling (GHS) use outmoded hazard-based schemes to evaluate cancer risks to the public. The authors note application of these approaches and classification schemes can lead to unfounded public concerns and reactionary public policies, for example, inappropriately placing consuming red meat in the same category as exposure to mustard gas.

“This hazard-identification only process places chemicals with widely differing potencies and very different modes of action into the same category.” said Professor Alan Boobis, PhD Imperial College London, Department of Medicine. “The consequences are unnecessary health scares and unnecessary diversion of public funds.”

The commentary recommends updating evaluation approaches by these and other international governmental organizations to utilize internationally accepted methodologies already used by many government regulatory bodies for cancer risk assessment using existing consensus-based frameworks including those of the World Health Organization’s International Programme on Chemical Safety (IPCS).

“Advances in the science of risk assessment and chemical risk management are not reflected in the outmoded IARC hazard-only evaluation approach,” said former U.S. Environmental Protection Agency Senior Science Advisor Rita Schoeney, PhD. “US EPA and other regulatory groups apply the most comprehensive and up to date approaches to their assessments in support of risk management decisions. This ensures that chemicals potentially toxic to humans are identified and exposure is minimized before adverse health effects are seen in populations.”

The authors note the continued use of outmoded hazard-only identification schemes also have serious consequences for society.

“Health scares triggered by recently published IARC reports have resulted in governments and public agencies responding with costly supplemental reviews and, in some cases, restrictions or bans on products which had significant public benefits,” said Timothy Pastoor, PhD, a former industry senior scientist. “By promoting and defending this solely hazard-based approach society loses important tools and often replaces them with less effective, sometimes more toxic alternatives with no basis in sound science.”

The authors conclude that hazard-only based research plays a role in risk assessment but is inadequate to guide appropriate risk management decisions. The authors urge the adoption of modern strategies that combine hazard and risk characterization to avoid unintended consequences of manufactured health scares, incurring unnecessary costs and diversions of public funds.

DECLARATION OF INTERESTS – This work did not receive any specific support from funding agencies in the public, commercial, or not-for-profit sectors. The authors’ affiliations are as shown on the cover page. The authors had sole responsibility for the writing and content of the paper. The views and opinions expressed in the paper are those of the authors, and do not necessarily reflect the views or policies of the authors’ current or former employers. (A full declaration including author affiliations can be found in the published paper.)

ABOUT THE JOURNAL – Regulatory Toxicology and Pharmacology is the Official Journal of the International Society for Regulatory Toxicology and Pharmacology, and reports the concepts and problems involved with the generation, evaluation, and interpretation of experimental animal and human data in the larger perspective of the societal considerations of protecting human health and the environment. The journal is devoted to reports of significant developments, public opinion, scientific data, and ideas that bridge the gap between scientific information and the legal aspects of toxicological and pharmacological regulations. The journal presents articles concerned with regulatory decisions and with the interpretation of scientific knowledge as influencing regulatory decisions. It is addressed to an International readership of scientists, program managers, research directors, attorneys, and business professionals.